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FDA 510(k) Application Details - K973565
Device Classification Name
Instrument, Biopsy
More FDA Info for this Device
510(K) Number
K973565
Device Name
Instrument, Biopsy
Applicant
COOK, INC.
925 SOUTH CURRY PIKE
P.O. BOX 489
BLOOMINGTON, IN 47402 US
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Contact
APRIL LAVENDER
Other 510(k) Applications for this Contact
Regulation Number
876.1075
More FDA Info for this Regulation Number
Classification Product Code
KNW
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More FDA Info for this Product Code
Date Received
09/19/1997
Decision Date
11/03/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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